Adenocarcinoma of PancreasNCT05374876
Hand Therapy Intervention Versus Traditional Occupational Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy
A study testing Hand Therapy Until CIPN and Traditional Occupational Therapy (TOT) in people with Adenocarcinoma of Pancreas, run by HonorHealth Research Institute at 1 site in United States.
Trial summary
A pilot randomized feasibility trial with a blinded evaluator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Pancreas
- What is being tested?
- Hand Therapy Until CIPN and Traditional Occupational Therapy (TOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2016to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination
- Patients who have no prior evidence of peripheral neuropathy of the hands
- Age 18 years or older
- Able to sit for minimum of 30 minutes for hand therapy sessions
Who cannot join
- Patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months
- Patients taking duloxetine or gabapentin
- History of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes
- Inability to sit for minimum of 30 minutes
- Documented cognitive problems limiting ability to participate in hand therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: Pilot Randomized Feasibility Trial Comparing Investigational Hand Therapy Intervention to Traditional Occupational Therapy Intervention to Prevent Chemotherapy-Induced Peripheral Neuropathy of the Hands in Patients Receiving Albumin Bound Paclitaxel + Gemcitabine Containing Combination Chemotherapy
A pilot randomized feasibility trial with a blinded evaluator.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) has a dose limiting effect which can greatly affect quality of life and often limits the amount of treatment patients can receive in treating their cancer. In the discipline of hand therapy, there is a science-based body of knowledge with effective protocols to treat neuropathies associated with injury and disease. These interventions have not been explored on patients with CIPN.
- Conditions
- Adenocarcinoma of Pancreas
- Being tested
- Hand Therapy Until CIPN, Traditional Occupational Therapy (TOT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Therapy Until CIPNOther
Patient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN.
Traditional Occupational Therapy (TOT)Other
Traditional occupational therapy intervention targeting compensatory strategies (TOT)
| Study group | Role | What they receive |
|---|---|---|
| Investigational hand therapy (IHT)] intervention targeting the nervous system | Experimental | Not described Receives: Other: Hand Therapy Until CIPN |
| Traditional occupational therapy intervention targeting compensatory strategies (TOT) | Other | Not described Receives: Other: Traditional Occupational Therapy (TOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
The number of participants reported to have chemotherapy-induced peripheral neuropathy (CIPN) as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Mean Time-to-Event for Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset
The mean time-to-event for chemotherapy-induced peripheral neuropathy CIPN) onset, as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, is reported here. The analysis was produced using the Kaplan-Meier method.
Measured: Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary outcomes (7)
Average Pain Score for Hand Pain
The average pain score for hand pain among participants. Participants were tested at 5 visits throughout the study, and the 5 visits were averaged to produce a single score per participant. The average of the single score among participants is reported here. Hand pain was measured using the Visual Analog Scale (VAS) to measure pain intensity. This scale consists of a 10-cm horizontal line with "no pain" (score = 0 cm) on the left and "worst pain imaginable" (score = 10 cm) on the right. Participants mark their pain on the line, and the score is measured in centimeters.
Measured: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Average Motor Function and Symptoms [QuickDASH Score]
Motor function and symptoms among participants were measured using the QuickDASH questionnaire. This is an 11-item questionnaire used to monitor physical function and symptoms over time in people with upper-extremity musculoskeletal disorders. QuickDASH outputs a total functionality score ranging from 0 (no disability) to 100 (most severe disability). Questions related to daily activities, interference of social activities, limitations to work, and severity of symptoms are scored on a 5-point Likert scale (1 - no difficulty, 2 - mild difficulty, 3 - moderate difficulty, 4 - severe difficulty, 5 - unable). Responses are input into the following mathematical formula to output the total functionality score: [(Sum of n responses / n - 1) * 25]. Scores of 0 - 30 are interpreted as mild to no disability, 31 - 60 moderate disability, and 61 to 100 as severe disability.
Measured: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Peripheral Nerve Tolerance at the Thoracic Level of the Right and Left Arm [Elevated Arm Stress Test (EAST)]
The number of participants with positive or negative peripheral nerve tolerance is reported here for both right and left arms as measured by the elevated arm stress test (EAST). EAST is a clinical provocation maneuver and is performed by holding the arms in a position of 90 degrees of abduction and external rotation ("stick-up position"). The patient then opens and closes the hands slowly for a period of 3 minutes. Reproduction of symptoms in the entire extremity or rapid fatigue of the extremity constitutes a positive test result. No reproduction of symptoms or rapid fatigue constitutes a negative result. Patients with thoracic outlet syndrome (TOS) typically have a positive test.
Measured: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Median Nerve Irritation at the Right and Left Wrist [Phalen's Test]
The number of participants with positive or negative median nerve irritation at the right and left wrist as measured by Phalen's test. This test is a neurological physical exam that involves passive flexion of the wrist for 15 to 60 seconds and reporting numbness/tingling. A positive test produces numbness and tingling in the distribution of the median nerve, while a negative test produces no numbness or tingling.
Measured: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Ulnar Nerve Compression at the Right and Left Arm [Elbow Flexion Test]
The number of participants with positive or negative ulnar nerve compression at the right and left arm as measured by the elbow flexion test. With the shoulder in neutral position, manual pressure is applied to the ulnar nerve in the cubital tunnel as the elbow is placed in terminal flexion with the forearm supported in supination. The wrist is maintained in a neutral position. The position is held for 60 seconds. A positive test reports numbness, tingling, or shooting pain in the forearm, hand, or fingers. A negative test reports no numbness, tingling, or shooting pain in the forearm, hand, or fingers.
Measured: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Cubital Tunnel [Tinel's Test]
The number of participants with positive or negative ulnar nerve injury at the right and left cubital tunnel as measured by Tinel's test. Tinel's test is a neurological physical exam administered as follows: with placing the patient's elbow fully flexed and the wrist held in neutral position, the examiner taps over the ulnar nerve at the cubital tunnel. A positive result causes tingling or pain, while a negative result causes no tingling or pain.
Measured: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Volar Wrist [Tinel's Test]
The number of participants with positive or negative ulnar nerve injury at the right and left volar wrist as measured by Tinel's test. Tinel's test is a neurological physical exam administered as follows: with placing the patient's elbow fully flexed and the wrist held in neutral position, the examiner taps over the ulnar nerve at the volar wrist. A positive result causes tingling or pain, while a negative result causes no tingling or pain.
Measured: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start13 May 2016
- Primary completion15 Sep 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gayle Jameson, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374876
- Sponsor's protocol ID
- AX-CL-PANC-PI-003347
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2021
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Journal articles
Publications
Jameson GS, Cooper C, Snyder C, Buchanan SM, Strelish T, Shearon T, Von Hoff DD, Bay C, Hull L, Kaatz LA, Borazanci EH. Hand therapy interventions for the prevention of chemotherapy-induced peripheral neuropathy of the hands in patients with pancreatic cancer. Oncologist. 2024 Dec 6;29(12):1095-e1778. doi: 10.1093/oncolo/oyae285.
PubMed 39436905
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Feasibility Trial Comparing Investigational Hand Therapy Intervention to Traditional Occupational Therapy Intervention to Prevent Chemotherapy-Induced Peripheral Neuropathy of the Hands in Patients Receiving Albumin Bound Paclitaxel + Gemcitabine Containing Combination Chemotherapy
- ClinicalTrials.gov ID
- NCT05374876
- Acronym / sponsor ID
- AX-CL-PANC-PI-003347
- Conditions
- Adenocarcinoma of Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Study start
- 13 May 2016 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot randomized feasibility trial with a blinded evaluator.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) has a dose limiting effect which can greatly affect quality of life and often limits the amount of treatment patients can receive in treating their cancer. In the discipline of hand therapy, there is a science-based body of knowledge with effective protocols to treat neuropathies associated with injury and disease. These interventions have not been explored on patients with CIPN.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational hand therapy (IHT)] intervention targeting the nervous system | Experimental | Other: Hand Therapy Until CIPN |
| Traditional occupational therapy intervention targeting compensatory strategies (TOT) | Other | Other: Traditional Occupational Therapy (TOT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination
- Patients who have no prior evidence of peripheral neuropathy of the hands
- Age 18 years or older
- Able to sit for minimum of 30 minutes for hand therapy sessions
Key exclusion criteria (5 listed)
- Patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months
- Patients taking duloxetine or gabapentin
- History of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes
- Inability to sit for minimum of 30 minutes
- Documented cognitive problems limiting ability to participate in hand therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Therapy Until CIPNPatient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN. | Other | Investigational hand therapy (IHT)] intervention targeting the nervous system |
| Traditional Occupational Therapy (TOT)Traditional occupational therapy intervention targeting compensatory strategies (TOT) | Other | Traditional occupational therapy intervention targeting compensatory strategies (TOT) |
Primary outcome
Number of Participants With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Time frame: Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
The number of participants reported to have chemotherapy-induced peripheral neuropathy (CIPN) as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Mean Time-to-Event for Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset
Time frame: Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
The mean time-to-event for chemotherapy-induced peripheral neuropathy CIPN) onset, as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, is reported here. The analysis was produced using the Kaplan-Meier method.
7 secondary outcomes
Average Pain Score for Hand Pain
Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Average Motor Function and Symptoms [QuickDASH Score]
Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Peripheral Nerve Tolerance at the Thoracic Level of the Right and Left Arm [Elevated Arm Stress Test (EAST)]
Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Median Nerve Irritation at the Right and Left Wrist [Phalen's Test]
Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Ulnar Nerve Compression at the Right and Left Arm [Elbow Flexion Test]
Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Cubital Tunnel [Tinel's Test]
Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Volar Wrist [Tinel's Test]
Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39436905Jameson GS, Cooper C, Snyder C, Buchanan SM, Strelish T, Shearon T, Von Hoff DD, Bay C, Hull L, Kaatz LA, Borazanci EH. Hand therapy interventions for the prevention of chemotherapy-induced peripheral neuropathy of the hands in patients with pancreatic cancer. Oncologist. 2024 Dec 6;29(12):1095-e1778. doi: 10.1093/oncolo/oyae285.
- Individual participant dataSharing planned: Undecided. Journal articles
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayle Jameson principal investigator
HonorHealth Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Therapy Until CIPN and Traditional Occupational Therapy (TOT) in people with Adenocarcinoma of Pancreas, run by HonorHealth Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Chemotherapy-Induced Peripheral Neuropathy (CIPN) (time frame: Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.